Status:
COMPLETED
Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers
Lead Sponsor:
Sylentis, S.A.
Conditions:
Ocular Pain
Dry Eye
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether SYL1001 is safe for the prevention and treatment of ocular pain and dry eye syndrome.
Eligibility Criteria
Inclusion
- Subjects must provide signed inform consent prior to participation.
- BMI between 19,5 y 29 kg/m2.
- Normal ocular test in both eyes: IOP \</=21 mmHg. BCVAof \>/=0,8 (20/25)Snellen scale, or \</=0.1 LogMar.
- Normal fluorescein Clearance Test in both eyes.
- Normal funduscopy in both eyes.
Exclusion
- Pregnant or breastfeeding females or those with a positive pregnancy test or who will not use a medically acceptable contraceptive method from selection and during the study.
- Current relevant disease.
- Previous chronic processes or with rebound characteristics that could interfere with study according investigator's judgment.
- Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
- Having used corticoids sporadically in the last 30 days whichever the route aof administration, or any med by ocular or nasal administration route.
- Case history of hypersensitivity to meds or any other allergic process.
- Visual alterations: previous eye surgery, glaucoma, use of lenses, uveitis or ocular surface pathology (dry eye, blepharitis).
- Volunteers with visual alteration with more than 3 dioptres in either eye.
- Volunteers who has participated in a clinical trial during the past fout months before study entry.
- Blood or derivate transfusion during the six previous months to study entry.
- Case history of drug or alcohol abuse or dependence.
- Positive result in test drug abuse during selection period.
- positive serology results to hepatitis B virus(HbsAg), virus C o VIH.
- Analytic alterations medically relevant, at investigator's judgement.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01438281
Start Date
July 1 2011
End Date
June 1 2012
Last Update
July 17 2012
Active Locations (1)
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1
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008